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Manufacturing Quality Control and Assurance Software Systems

Web-based Manufacturing Quality Control and Assurance Software Systems for Total Quality Management (TQM) Across the Enterprise

To be competitive in the cutthroat global market, most general manufacturers strive to meet ISO quality standards, such as ISO 9000 and ISO 13485. Both standards are concerned with quality management and fulfilling customer and regulatory requirements through continuous improvement of the manufacturing quality control system.

Many general manufacturers also adhere to the principle of Total Quality Management (TQM), which was developed in the 1940s by W. Edwards Deming. This management approach in a manufacturing quality assurance system focuses on long-term success through customer satisfaction. Both TQM and ISO emphasize improving processes, products, and services and incorporating quality in all aspects of daily operations.

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Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?

Automating Quality Compliance and Business Process within the Food and Beverage Industry

ISO 13485 - Change? Do I Have To??

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Compliance and Technology: How to meet changing FDA expectations

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A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)

What is Quality Control?

Quality control is a concept incorporated by manufacturing companies in the system to review all processes and ensure that a certain standard is maintained during production. MasterControl’s manufacturing quality assurance software system is an integrated quality management suite that caters to the demanding needs of manufacturing companies around the globe. The main intent of MasterControl solution is to provide customers with an off-the-shelf easy-to-use software system that is designed to foster quality throughout the enterprise.

MasterControl's Manufacturing Quality Assurance Software Systems

The MasterControl manufacturing quality assurance software suite consists of the following integrated applications:

Manufacturing Document Control Software

Manufacturing companies find difficulty in providing all employees with updated documents pertaining to standard operating procedures (SOPs). This causes non-conformity in the way procedures are carried out as various departments consult different versions of the same SOP. Eventually, the end product does not adhere to the standards as it is manufactured with a deviance in the application of correct set of procedures. Because of this, manufacturing companies are provided with document control through MasterControl’s manufacturing quality control software and its online web-based platform that helps increase the quality unit's efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes.

MasterControl’s Documents module presents users with virtual vaults through which employees access and update documents. This makes searching and retrieval of documents a relatively easy task. MasterControl Documents, when integrated with the MasterControl’s manufacturing quality management software suite, provides an interactive forum for management to perform different functions such as change control, customer complaints, corrective/preventive action (CAPA), audits, etc., for a closed-loop solution.

Manufacturing Quality Assurance and CAPA System

Once a deviance is spotted in SOPs, the next step is to correct the nonconformity and ensure that its occurrence is prevented in future. This requires the integration of a system—such as MasterControl's manufacturing quality assurance and CAPA solution —that features different quality subsystems track incidents and can escalate them into corrective actions. We take pride in offering a best-practice "8D" process that guides the quality team through every step of CAPA implementation, from identification of the problem through corrective action. With MasterControl management can launch a CAPA form directly from another form. For example, a CAPA is launched through nonconformance or deviation report which automatically retrieves the entered relevant data into the CAPA form. This helps in reducing data entry and eliminating errors inherent to manual transfer of information. The manufacturing quality control software system is accessible through the internet so that customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to a CAPA.

Manufacturing Quality Assurance Change Control Software

With business expanding to different horizons, manufacturing companies want a faster turnaround so that production of goods takes less time. MasterControl's manufacturing quality assurance and change control software streamlines the entire change control process and makes the entire system efficient for production. Utilizing the best-practice forms, prioritization of risks is simplified. This enables management classify change and to assess risks as low, medium, or high. Any high-level change such as change in design, look, and feel of the product or any enhancement implies great impact on the product. Such a change demands extensive alteration in existing documentation and is likely to require regulatory filing that can be more readily facilitated with MasterControl’s manufacturing quality assurance software systems. Moreover, manufacturing quality control software provides management with customizable reports for monitoring real-time status not only of change control tasks but of the entire quality system.

Manufacturing Training Management

As companies recruit new employees, it is likely that these employees require a comprehensive orientation of the company’s business. MasterControl training software is specially designed to meet needs of any small or large scale organization for training employees about various aspects of business. It automates assignment and monitoring of training tasks and grading of online exams. As training courses are sequenced, once a prerequisite course is completed, the next one is automatically launched. The group sign-off feature solves the problem of verifying training of large groups of employees. As all MasterControl products can be integrated with the rest of the manufacturing quality assurance system, so can the training solution. This presents management with the option of documenting any change in process and automatically invoking training tasks upon approval of a change.

Manufacturing Nonconformance Automation Software

Manufacturing companies deal with production of components, parts, and finished products. As these companies must adhere to FDA and ISO regulations, this means they can lose out on regulatory approval in the case of any nonconformity in executing processes. MasterControl Nonconformance is a robust solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling any nonconformity in the manufacturing quality control system. A five-step process connects all responsible personnel so that they are able to effectively communicate and collaborate for timely disposition of a nonconformance. Depending on the size of the organization, the solution offers the choice of maintaining a stand-alone nonconformance process for small-scale or localized incidents. It can also connect to the CAPA process for automatic escalation when the situation warrants it.

Manufacturing Quality Control and Audit Management Software

To keep a check on feasibility of different business process areas, companies run regularly scheduled audits. This ensures that processes and departments are able to produce optimum outcome by completely utilizing the available resources. MasterControl quality control and audit software automates, streamlines, and effectively manages the audit process. In order to closely monitor the processes, the software provides advanced tracking capability so that each stage—including scheduling, planning, execution, and completion—is carefully examined. Users can track basic information and analyze the audit findings through the advanced analytics and reporting capabilities. In this way managers get a real-time view of the audit process.

Manufacturing Customer Complaints Software

In order to continually improve business, it is imperative to include customer feedback in the system. Customers can interact with management by submitting complaints. This helps in understanding the weaker areas that require immediate attention. MasterControl Customer Complaints is a web-based software solution that streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. This ensures implementation of a good manufacturing quality assurance system. The software provides users with a pre-configured three-step process that consists of a multi-page form. The process starts with the processing of a customer complaint, automatically moves to internal investigation, and concludes with a resolution of the issue. With MasterControl's advanced reporting capabilities, management is able to gain increased oversight and demonstrate appropriate controls to regulatory agencies.

Manufacturing Forms-Based Processes Automation

Manufacturing companies undertake a huge number of processes which means the sheer amount of documentation pertaining to these processes is also large. With companies depending on paper-based systems, filling out forms with accurate data can be cumbersome as there are obvious chances of errors in manual data entry. MasterControl offers a forms-based manufacturing quality assurance system which automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. Users are prompted to select data that reduces manual data entry and helps avoid mistakes common in manual systems. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to HTML and then can be imported in MasterControl's manufacturing quality control software. This way, users are familiar with the same form and won't need new training. Moreover, a company may also customize existing forms or design new ones to suit its needs.

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The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.